Update on the Placing on the Market of Medical Devices and Personal Protective Equipment (PPE) such as (Respiratory) Masks in the Context of the Coronavirus Crisis
In our posts dated 1 April 2020 (LINK) and dated 2 April 2020 (LINK) we informed about the placing on the market of medical devices and personal protective equipment in the context of the corona crisis. Taking current developments into account, we provide the following update.
1. Export Restrictions on Personal Protective Equipment du to the Comission Implementing Regulation (EU) 2020/402 of 14 March 2020
On 14 March 2020 the European Commission adopted the Implementing Regulation (EU) 2020/402 on the making the exportation of certain products subject to the production of an export authorisation. The Regulation has entered into force on 15 March 2020 (LINK). The Regulation will apply for six weeks. According to the Regulation, the export of personal protective equipment is subject to an authorisation. An export authorisation is required regardless of whether the goods originate in the European Union or not. It is required for protective spectacles and visors, face shields, mouth-nose-protection equipment, protective garments and gloves. In Germany, an application for export authorisation must be made at the Federal Office of Economics and Export Control (Bundesamt für Wirtschaft und Ausfuhrkontrolle). The export ban applies to all non-EU countries. The states of Norway, Iceland, Liechtenstein and Switzerland are excluded from the scope of the Implementing Regulation (EU) 2020/402 (LINK). This also applies to overseas countries and territories, the Faroe Islands, Andorra, San Marino and Vatican City.
The Federal Ministry for Economic Affairs and Energy had already ordered on 4 March 2020 and 12 March 2020 that the export of relevant personal protective equipment is prohibited.
This also applied to exports to other EU states. On the basis of the Implementing Regulation (EU) 2020/402, the Federal Ministry for Economic Affairs and Energy revoked the order on 19 March 2020.
2. Guidelines of the European Commission dated 27 March 2020
On 30 March 2020 the European Commission has published Guidelines on Conformity Assessment Procedures for Protective Equipment dated 27 March 2020 (LINK). The guidelines are addressed to prospective manufacturers of protective equipment. According to the European Commission, they will be complemented on a regular basis.
The EU Commission states in the Guidelines that masks and other equipment used in the COVID-19 context that are covered by the PPE Regulation are considered as 'PPE of Category III'. Therefore, a notified body must be involved in all cases which will test the product prior to placing on the market (conformity assessment procedure).
The Guidelines further refer to the recommendation issued by the Commission on 13 March 2020 and explain the exceptions proposed in the recommendation when PPE may be already placed on the market even if the conformity assessment procedures have not yet been finalised or even initiated:
- If national market surveillance authorities find that equipment in the EU market ensure an adequate level of health and safety in accordance with the essential requirements set out in EU law, they may authorise these products on the EU market, even though the conformity assessment procedures, including the affixing of CE marking, have not been fully finalised.
- In exceptional circumstances, products can be placed on the market even if the certification procedures have not been initiated and no CE marking has been affixed upon them, if the following cumulative conditions are fulfilled:
- The products are manufactured in accordance with one of the EN standards or in accordance with any of the other standards referred to in the WHO guidelines or a technical solution ensuring an adequate level of safety;
- the products are part of a purchase organised by the relevant Member State authorities;
- the products are only made available for the healthcare workers;
- the products are only made available for the duration of the current health crisis; and
- the products are not entering the regular distribution channels and made available to other users.
The Guidelines further refer to the shortened testing procedures for respiratory masks developed by DEKRA and IFA. In this regard, the Central Office of Federal States for Safety Technology (Zentralstelle der Länder für Sicherheitstechnik) pointed out in its communication dated 1 April 2020 that this accelerated testing procedure does not, however, constitute a conformity assessment in accordance with the PPE Regulation and is not intended to replace it (LINK). However, the successful completion of the accelerated testing procedure can be used as a basis for the decision of the competent authorities with regard to the exceptions proposed in the recommendation of the EU Commission.
3. Regulation of 8 April 2020 on the Procurement of Medical Devices and Personal Protective Equipment
In the course of the Recommendation and the Guidelines of the European Commission, the Federal Ministry of Health ("BMG") has initiated an open-house procedure as an organised procurement process. Under this procedure, the BMG purchases protective equipment at a fixed price and distributes the products to the federal states of Germany and health insurance associations. The subject of this procedure is the conclusion of supply contracts for protective equipment. As part of such organised procurement procedures, the BMG issued the "Regulation on the Procurement of Medical Devices and Personal Protective Equipment for the Epidemic Caused by the Coronavirus SARS-CoV-2" which came into force on 10 April 2020(LINK). Under the Regulation the Federal Republic of Germany is an importer of medical devices and personal protective equipment within the meaning of the Medical Devices Act (MPG) and the PPE Regulation, if it has medical devices or personal protective equipment brought into the territory of the Federal Republic of Germany as part of a procurement programme commissioned since 27 March 2020. The natural or legal persons commissioned by the Federal Republic of Germany with the introduction are not themselves importers. Along the lines of the Recommendation and Guidelines of the EU Commission, the Regulation also stipulates that the products imported within the scope of the procurement procedure may only be sold to the group of persons designated by the Federal Ministry of Health. They may not be put into circulation via the usual distribution channels for these products and may not be sold to any other group of persons than the group of persons determined by the Federal Ministry of Health. In addition, the Regulation stipulates that the provisions also apply accordingly if a federal state, in coordination with the Federal Ministry of Health, has medical devices or personal protective equipment introduced to Germany as part of a procurement programme commissioned by it since 27 March 2020. In this case, the federal state is an importer within the meaning of the Medical Devices Act (MPG) and the PPE Regulation.
Dr Silke Dulle
Rechtsanwältin, Licensed Specialist for Medical Law